Moxifloxacin Ophthalmic Solution USP — Class III drug recall D-0517-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-03-06, distributed nationwide. Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-
| Recall number | D-0517-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-02-26 |
| Classified | 2019-02-28 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2020-06-22 |
| Distributed | Nationwide (US) |
| Quantity | 674,628 bottles |
| Reason classes | specification failure |
| NDC | 68180-0422, 68180-0422-01 |
| Lot numbers | H701618, H701619, H701620, H702220, H702221, H702222, H702223, H702224, H702225, H702351, H702971, H702972, H702973, H702974, H703151, H703152, H703153, H703155, H703682, H703683, H704243, H704245, H704247, H704707, H704709, H705038, H705039, H705561, H800394, H800395, H800617, H800618, H801585, H801586, H801721, H801722, H802138, H802139, H802140, H802421 and 22 more |
| Expiration dates | 2019-03-20, 2019-04-20, 2019-06-20, 2019-07-20, 2019-09-20, 2019-10-20, 2019-11-20, 2020-01-20, 2020-03-20, 2020-04-20, 2020-05-20, 2020-06-20, 2020-07-20, 2020-09-20, 2020-11-20, 2020-12-20 |
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Reason for recall
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0517-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.